Associate Director – CMC Program Management

Associate Director – CMC Program Management

Requirements

• Bachelor’s and/or MS degree in scientific discipline or related field required.
• 7-10+ years of experience managing and leading projects/programs within the biopharmaceutical industry with strong participation in project teams.
• Expertise in CMC drug development pertinent to cell/gene therapy manufacturing preferred.
• Knowledge of regulatory guidelines and/or regulatory experience preferred.
• Demonstrated success in leading and negotiating in a matrix-based organization.
• Excellent knowledge of project management discipline and its application to drug development required to deliver time, cost, quality, and risk management to teams.
• Superior interpersonal skills, communication skills and ability to manage conflicts and negotiations while providing impact and influence.
• Strong organizational, analytical, and problem-solving skills.
• Ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Familiarity with project management software such as MS project, Smartsheet, think cell.
• Work independently to manage multiple projects simultaneously, making decisions and adjustments as necessary to meet deadlines and goals.

Responsibilities

• Ensure that projects/deliverables adhere to program and business goals by developing and driving project plans, capturing assumptions, managing cross-functional teams, and coordinating activities within the established project timelines set forth by the Technical Program Lead and/or project team.
• Integrate timelines and strategies across functions, identifying and addressing interdependencies.
• Support scenario planning and identification of acceleration opportunities.
• Monitor project progress continuously and make scheduled reports on measurable items, such as milestones and deliverables.
• Identify and track risks and ensure mitigation strategies are captured and implemented.
• Communicate proactively with all involved personnel to provide encouragement, identify problems, create solutions, and implement efficiency improvements.
• Contribute to regular program reviews (project/portfolio reviews, program strategy meetings, program risk management meetings) to accelerate program advancement, identify early critical success factors, and mitigate program risk.
• Drive CMC development strategies, activities, and timelines with responsible teams (process development, analytical development, operations, quality, regulatory) ensuring alignment with line functions and across strategic/operational plans.
• Contribute to the creation integrated project budget and resource plan in partnership with Technical Program Lead and/or functional line representatives.
• Responsible for ensuring effective, accurate and timely communication of project information (meetings, minutes, action items) and coordinates interfaces with other departments.
• Hold functional teams accountable for committed objectives and timelines.

Preferred Qualifications

• PMP certification preferred.
• Cell/Gene Therapy experience preferred.